Consumer Lawyers

Archive for the ‘FDA REcalls’ Category

Pure Edge Nutrition, LLC Issues Nationwide Recall of Bella Vi Brand Products Due to Undeclared Sibutramine and Phenolphthalein

In FDA REcalls on March 29, 2014 at 5:46 pm

Pure Edge Nutrition, LLC is voluntarily recalling one lot of each: Bella Vi Insane Bee Pollen Capsules, Bella Vi BTrim Ultimate Boost, Bella Vi BTrim Max, Bella Vi Extreme Accelerator, Bella Vi Insane Amp’d, and two lots of Bella Vi Amp’d Up to the consumer level. The products have been found to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein through FDA laboratory analyses. Sibutramine a previously approved controlled substance, was removed from the US market in October 2010 for safety reasons, Phenophthalein is used medicinally as a laxative and not approved for marketing in the US. Therefore, these products are unapproved new drugs.

Products containing sibutramine and phenophthalein pose a threat to consumers because Sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking. To date, the company has not received any reports of adverse events related to this recall. The recall was initiated after discovering the Sibutramine and Phenophthalein were included as ingredients by the manufacturer.

All affected products are marketed as dietary supplements for weight loss and were packaged and distributed as follows:

Bella Vi Insane Bee Pollen Capsules is packaged in bottles of 60 capsules with lot # 201303 EXP: 14/03/07. Bella Vi Insane was distributed to consumers and distributors nationwide from March 1, 2013 – August 31, 2013.

Bella Vi BTrim Max is packaged in bottles of 60 capsules with lot # BTX13 EXP: 2015/08/15. Bella Vi Btrim Max was distributed to consumers and distributors nationwide from August 31, 2013 – September 31, 2013.

Bella Vi BTrim Ultimate Boost is packaged in bottles of 30 capsules with lot # BTRM3452 EXP: 2015/07/03. Bella Vi Btrim was distributed to consumers and distributors nationwide from July 1, 2013 – September 31, 2013.

Bella Vi Extreme Accelerator is packaged in bottles of 30 capsules with lot # BTRX7654 EXP: 2015/07/08. Bella Vi Extreme was distributed to consumers and distributors nationwide from July 1, 2013 – September 31, 2013.

Bella Vi Insane Amp’d is packaged in bottles of 60 capsules with lot # VINA2013 EXP: 2015/06/12. Bella Vi Insane Amp’d was distributed to consumers and distributors nationwide from June 1, 2013 – September 31, 2013.

Bella Vi Amp’d Up is packaged in bottles of 60 capsules with lot # AU2013AB EXP: 2015/05/20 and lot #BVAU813 EXP: 2015/08/12. Bella Vi Amp’d Up was distributed to consumers and distributors nationwide from May 1, 2013 – September 31, 2013.

Advertisements

Pain Free by Nature Recalls Reumofan Plus Tablets Due to Undeclared Drug Ingredients

In FDA REcalls on March 29, 2014 at 5:45 pm

Pain Free By Nature is recalling “Reumofan Plus” Tablets purchased through their website at http://www.painfreebynature.com, because they contain undeclared active pharmaceutical ingredients: methocarbamol and diclofenac. Use of this product could result in serious and life-threatening injuries.

Reumofan Plus is used as a treatment for muscle pain, arthritis, osteoporosis, bone cancer and other conditions. This product comes in thirty (30) tablet containers and is packaged in a green and gold box. Reumofan Plus was distributed nationwide through internet sales.

The recall was initiated after the US Food and Drug Administration discovered that the product was distributed in packaging that did not reveal the presence of the active pharmaceutical ingredients, making it an unapproved drug.

Pain Free By Nature did not manufacture the product but did distribute to customers nationwide. Distribution has been completely terminated by the company.

Consumers that have Reumofan Plus should be aware that the product may pose a serious health risk. Consumers who are taking these products or who have recently stopped taking Reumofan Plus should immediately consult a health care professional. Consumers who have purchased the thirty (30) tablet containers of Reumofan Plus are urged to return all unopened bottles to; Pain Free By Nature, LLC, Attn: Nilsen, 211 West 11th Street, Harper, KS, 67058. Refunds will be mailed immediately following processing.

Homeopathic remedies recalled

In FDA REcalls on March 29, 2014 at 5:40 pm

Terra-Medica, Inc. is voluntarily recalling 56 lots of Pleo-FORT, Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX homeopathic drug products in liquid, tablet, capsule, ointment, and suppository forms to the consumer level. FDA has determined that these products have the potential to contain penicillin or derivatives of penicillin, which may be produced during the fermentation process.

In patients who are allergic to beta-lactam antibiotics, even at low levels, exposure to penicillin can result in a range of allergic reactions from mild rashes to severe and life-threatening anaphylactic reactions. To date, Terra-Medica has not received any reports of adverse events related to this recall, nor any reports of product tests indicating penicillin content in the products.

The products are used as homeopathic drugs and have a label stating “Distributed by SANUM USA Corp.” The affected products are identified by package size, batch (lot) number and expiry date (ranging from March 2014 – May 2018) in the table accompanying this release. The batch number can be located at the side panel on the label. The affected products were distributed nationwide through health care practitioners, who may have sold the products through websites.

Terra-Medica is notifying its customers by letter and email and is arranging for return of all recalled products. Consumers and distributors that have product which is subject to the recall should stop using the products and return them to the point of purchase.

 

http://www.fda.gov/Safety/Recalls/ucm389832.htm

 

GSK recalls weight-loss drug Alli in U.S. on tampering concerns

In FDA REcalls on March 29, 2014 at 5:37 pm

Alli is a turquoise pill. The tainted bottles may contain tablets and capsules of different shapes and colors.

– The outer carton may look authentic.
– The bottle may contain a range of tablets and capsules of various shapes and colors.
– The bottle may not have a label.
– The bottle’s tamper evident seal may not be intact, not be made of foil and/or not have the authentic alli wording: “Sealed for your Protection.”
– The lot numbers and expiration dates on the bottle do not match the lot number and expiration date on the outer carton.
– To date, some bottles bearing the following lot numbers and expiration dates on the carton have been reported to GSK by consumers as containing product other than alli.
– Carton Lot 14372, Expiration: 02/28/2016
– Carton Lot 14395, Expiration: 02/28/2016
– Carton Lot 14124, Expiration: 09/30/2015
– Carton Lot 14267, Expiration: 01/31/2016
– Carton Lot 14442, Expiration: 04/30/2016

Lipari Foods Recalls Sunflower Seeds

In FDA REcalls on June 22, 2013 at 8:32 pm

Lipari Foods of Warren, MI is recalling Raw Sunflower Seeds, Roasted Sunflower Seeds and Snack Mixes, because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

Raw Sunflower Seeds, Roasted Sunflower Seeds, and Snack Mixes were distributed from April 5th 2013 to June 11th 2013 to manufacturers and retailers in the following states: Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.

In total there are 52 items affected by this recall. Please see attached documentation for complete list of products including UPC and lot codes. Detailed information will be mailed out to each store affected by the recall.

 

http://www.4-traders.com/news/FDA-Food-and-Drug-Administration-Lipari-Foods-Recalls-Sunflower-Seeds-and-Snack-Mixes-Because-of–17024034/

Endologix’s Catheter Introducer Device Recall

In FDA REcalls on June 22, 2013 at 8:31 pm

The FDA designated an Endologix (NSDQ:ELGX) warning over a catheter introducer as a Class I recall, meaning the device could seriously injure or kill patients.

The Irvine, Calif.-based company received reports that the dilator component of its AFX introducer system can break off during procedures.

Endologix sent a letter to customers in Florida, Indiana, Michigan, New Hampshire, New Jersey and New York, the only states where the defective introducer system was distributed.

Medtronic recalls surgical breathing tube

In FDA REcalls on June 22, 2013 at 8:30 pm

Medtronic Inc. has recalled a breathing tube used during surgery that could collapse and imperil a patient’s breathing if handled incorrectly, the Food and Drug Administration said Friday.

It was the first public mention of the problem but the Fridley-based medical device marker said the recall was begun in March and completed in April, and that no deaths or injuries were reported. The product, called a NIM Trivantage EMG Endotracheal Tube, was manufactured at Medtronic’s Jacksonville, Fla., operations.

The FDA announced the recall on its website Friday because it had classified the recall’s degree of seriousness. It was classified a Class One recall, which the FDA said on its website means “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

The endotracheal tube is used during surgery for ventilation and for monitoring the muscles of the voice box. A cuff around the tube, used to close the gap around the tube that delivers air and anesthesia, can become deflated if the device is handled incorrectly. This may require a doctor to reinflate the cuff or replace the tube to make sure the patient can continue to breathe.

 

http://www.startribune.com/business/212548691.html

Beta Labs, LTD Announces Recall of Oxyphen, Phentalene, Phen FX, and Red Vipers

In FDA REcalls on June 22, 2013 at 8:29 pm
Beta Labs, LTD (“Beta”), dietary supplement retailer, is recalling Oxyphen XR Lot #s 200910 and 200911, Phentalene Lot # 58800512, Phen FX Lot # 1205129, and Red Vipers Lot # 1205128 (hereinafter referred to as the “Products”). The recall was initiated on June 15, 2013, after a review of recent FDA communications related to 1,3 dimethylamylamine (“DMAA”). The Products contain DMAA.
The UPC codes for each of the products are: Oxyphen XR, 70541 59974; Phentalene, 70541 59982; Phen FX, 29882 55980; Red Vipers, 29882 55981. The Products are all in capsule form.
DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. The Food and Drug Administration (FDA) has warned that DMAA is potentially dangerous to health.
See http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm347270.htm. Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems. A number of adverse effects associated with DMAA containing dietary supplements have been reported to the FDA. The FDA has also warned that DMAA is not a dietary ingredient and thus, is not Dietary Supplement Health and Education Act (DSHEA) compliant.
This recall affects Oxyphen XR Lot #s 200910 and 200911, Phentalene Lot # 58800512, Phen FX Lot # 1205129, and Red Vipers Lot # 1205128. The products are in capsule form.

Relapse of Fungal Meningitis Seen Months Later

In FDA REcalls on May 30, 2013 at 6:41 pm

The fungal meningitis tragedy is still ongoing.

An 80-year-old Virginia man, discharged after more than 4 months of therapy, relapsed and needed additional treatment less than a month after discharge, according to Rachel Smith, MD, of the CDC, and colleagues at the agency and in Virginia.

The case illustrates the possibility of relapse despite lengthy therapy and resolution of signs and symptoms, Smith and colleagues reported online in the New England Journal of Medicine.

On the other hand, they noted, the CDC knows of similar patients who have not relapsed after stopping antifungal therapy but “the risk of relapse should be considered” when doctors decide to discontinue treatment.

The outbreak started in late September, 2012, when Tennessee doctors began treating a man for an unusual form of meningitis that did not seem to have a bacterial or viral cause.

Eventually, they found evidence of a fungal infection — with the mold Aspergillus fumigatus — and notified the state’s public health authorities.

 

http://www.medpagetoday.com/Neurology/GeneralNeurology/39464

Enhanced by Zemanta

Animas Corporation 2020 Insulin Infusion Pump: Class I Recall – False Alarm or Warning Sound

In FDA REcalls on April 8, 2013 at 2:51 pm

SSUE: Animas identified a component issue affecting Animas 2020 Infusion Insulin Pumps manufactured from March 1, 2012 to November 30, 2012. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following:

  • “Loss of prime”
  • “Occlusion”
  • “No Cartridge detected”

If you receive any of these alarms, the pump may prompt you to complete the rewind, load and prime sequence to clear this alarm. Failure to follow the pump’s safety instructions and disconnect your infusion set from your body before the “rewind, load and prime” steps can lead to unintended delivery of insulin, placing you in danger of potential serious health risks, such as hypoglycemia.

The Animas 2020 Insulin Pump also has a software limitation that will impact the ability of the pump to function past December 31, 2015. After this date, the pump will no linger deliver insulin and will generate a “Call Service Alarm.”

BACKGROUND: The Animas 2020 Insulin Pumps are used to deliver insulin directly into your blood for the treatment of diabetes.

RECOMMENDATION: Customers with the device should contact Animas’ Product Fulfillment Center at 877-280-2339 between the hours of 6 a.m. and 12 a.m. EST to schedule shipment of your free replacement pump. Customers with technical questions or who want to report a concern should contact Customer Technical Support Center at 866-793-5253.

 

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm346788.htm